Quality Management Systems

Fluorochem is registered to standard ISO9001:2008 with BSI certificate number FS26123. We can supply a copy of the certificate on request.

Product Specifications & Certificate of Analysis

Certificates of Analysis (CofA) report batch specific information and are available for all of our products. A CofA for your product may be available at your request from our Technical Service group, and/or
included with your shipment.

Analytical Test Methods

A number of the analytical methods used by the Quality Control department to test Fluorochem products are available for your review. Specific analytical methods can be requested from our Technical Service
groups. Depending on the request, Fluorochem reserves the right to disclose certain information under a Confidentiality Disclosure Agreement. Fluorochem is able to develop custom analytical methods and
to integrate additional testing for custom-made or customized products in order to tailor the testing to best fit your needs.

Quality Control Facilites

Fluorochem QC Suite

Thermo-Scientific Trace DSQ-II GC-MS

Jasco 4100 FT-IR

Mettler Toledo autotitration

Mettler Toledo Karl Fischer water content titration system

MP70 Metler Toledo melting point determination

Jasco P-2000 Polarimeter

External facilities available on demand

1H, 19F and 13C nmr

Chiral LC-MS

Quality Responsibilities

Qualification and validation activities

Control of documents

Batch record review

Product release

Investigation of non-conformances

Risk assessment

Implementation of corrective and preventive actions

Change control and customer notifications

Training

Internal, customer and regulatory audits

Supplier qualification and audits

Review and approval of final and raw material product specifications

Review and approval of all manufacturing and packaging documents and operating procedures